FCE and SID Exclusions
U.S. FDA CITATION: 21 C.F.R. § 108 Subpart B (2015), 21 C.F.R. § 113 (2015), & 21 C.F.R. § 114 (2015)
U.S. FDA FCE-SID regulations are complicated and contain numerous “exclusions” (exceptions) for various low-acid or acidified products depending on factors such as processing method, pH changes during processing, etc.
U.S. FDA inspectors may not always know merely by looking at the package whether a process filing (“SID”) is required. In such circumstances, the inspector could detain the product, send samples for laboratory testing, and request processing information from the manufacturer. Such detentions could last weeks. FCE-SID Exclusion Certificates issued by Registrar Corp address this potential problem by:
- Helping manufacturers determine whether an exclusion applies and then compiling and organizing adequate evidence that the food is excluded from the SID requirement
- Assisting the company in preparing documentation of the product’s exclusion status in a format that allows a U.S. FDA inspector to easily, quickly, and reliably confirm that a process filing is not required
- Helping manufacturers communicate with U.S. FDA in the event of a detention